It is known to employ levamisole, an immunomodulator as an anti-rheumatic agent, e.g., in the treatment of the inflammatory disease rheumatoid arthritis, thus see Scott, Annals of the Rheumatic Diseases, Vol. 37 (1978) pages 259-261, Miller, Arthritis and Rheumatism, Vol. 23, January, 1982, pages 10-16, Barada, Arthritis and Rheumatism, Vol. 25, January, 1982, pages 10-16, Huskison, The Lancet, Feb. 21, 1976, pages 393-395, Veys, The Lancet, Apr. 10, 1976, pages 808-809, Vischer, The Lancet, Nov. 11, 1978, pages 1007-1012. Levamisole in all of these studies was employed with patients maintained throughout the studies on practically fixed doses of pure anti-inflammatory drugs. Levamisole chemically is (-) 2,3,5,6-tetrahydro-6-phenylimidazo[2,1-b]thiazole.
Inosiplex is an immunomodulating agent. It is the p-acetamidobenzoic acid salt of N,N-dimethylamino-2-propanol:inosine complex 3:1 molar ratio. It is available commercially as Isoprinosine, and its manufacture and many of its uses are described in Gordon U.S. Pat. No. 3,646,007, Gordon U.S. Pat. No. 3,728,450, and Gordon U.S. Pat. No. 3,857,940. The entire disclosure of the Gordon patents is hereby incorporated by reference and relied upon.
Wybran, J. Rheumatology, Vol. 8:4, 1981, has reported that inosiplex tested favorably in treating rheumatoid arthritis. The patients were stabilized on an optimum antiinflammatory regimen which remained constant in the study. This work of Wybran and co-workers was also reported by Appelboom in a Presentation at the 2nd International Seminar on the treatment of Rheumatic Diseases in Israel Nov. 24-28, 1981. The regimen included the non-steroidal anti-inflammatory drugs indomethacin (100-150 mg) or aspirin (3 grams). This is shown in a letter of May 5, 1982, from Wybran and Appelboom to the present inventor and also a letter of Aug. 2, 1982, from Dr. Simon of Newport Pharmaceuticals International, Inc., to Dr. Wybran, which letter was acknowledged by Dr. Wybran on Aug. 9, 1982.